Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)

Last updated: March 31, 2011
Sponsor: The Canadian College of Naturopathic Medicine
Overall Status: Completed

Phase

1/2

Condition

Ulcers

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT01176227
1001
  • Ages 18-64
  • All Genders

Study Summary

The Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and bloating.

The medicines that are currently used to help people with IBS are not as effective as we would like them to be. These medicines are usually only prescribed to reduce the pain of IBS and not actually treat the disorder itself. Recently, scientists have found that probiotics (beneficial bacteria that live inside humans) may help reduce the painful symptoms and diarrhea that are part of IBS.

This research is being conducted to determine whether this particular combination of three probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum) will reduce the symptoms of IBS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects aged 18-64

  • A diagnosis of Irritable Bowel Syndrome as per ROME III criteria

  • A classification of mild irritable bowel syndrome as indicated by the Irritable BowelSeverity Scoring System (score >75)

  • Female subjects currently using an acceptable form of birth control who agree tomaintain its use throughout the study (e.g. abstinence, oral contraceptives, barriermethods)

  • Subjects who agree to maintain their current eating habits throughout the study

  • Ability to understand and sign the Informed Consent Form

Exclusion

Exclusion Criteria:

  • Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant inthe next three months

  • Subjects currently receiving medication for the treatment of IBS symptoms

  • Subjects currently receiving natural health products for treatment of IBS symptomswill be eligible for inclusion in the trial is they agree to undergo a two weekwashout period

  • Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severeabdominal pain

  • Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoinglong-term corticosteroid treatment)

  • Subjects currently receiving antibiotic therapy or antibiotic therapy within theprevious month

  • Subjects regularly consuming probiotic containing products (e.g. yogurts, etc.)

  • Subjects who have recently (< 3 months) initiated dietary measures to control IBSsymptoms

  • Subjects with a history of major or complicated gastrointestinal surgery

  • Subjects with severe endometriosis

  • Subjects with malignant tumors or subjects undergoing chemotherapy or radiationtherapy

  • Subjects with severe IBS and that require medication

  • Subjects with weight loss, anaemia, inflammatory bowel disease, celiac sprue, familyhistory of colorectal cancer

  • Subjects exhibiting or indicating thoughts of suicide currently or in the past asbased on patient screening interview by the investigator/clinician. Appropriatereferral to a health care provider will be provided

  • Subjects with known allergies to milk or milk based products

  • Subjects using and/or have used antipsychotic or anticholinergic medication within theprior month, those with reported significant abnormalities on the thyroid functiontests, blood counts and serum chemistry

  • Subjects 50 years or older who have been diagnosed with IBS and have not received acolonoscopy in the last five years.

Study Design

Total Participants: 128
Study Start date:
May 01, 2010
Estimated Completion Date:
February 28, 2011

Study Description

The purpose of this trial is to investigate the effects of the three strain probiotic, Kyo-Dophilus, on the symptoms associated with Irritable Bowel Syndrome.

The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with Irritable Bowel Syndrome by ROME III criteria and classified as mild through the Irritable Bowel Severity Scoring System and to measuring quality of life and global well being of patients through the Visual Analog Scale and the Irritable Bowel Syndrome-Quality of Life Questioner. The secondary objective is to assess the tolerability of the treatment through the use of study diaries.

Connect with a study center

  • The Canadian College of Naturopathic Medicine

    Toronto, Ontario M2K 1E2
    Canada

    Site Not Available

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